FDA Adverse Event Other Summary report: N

ESSURE COILS

MDR report key: 23427484 · Received October 29, 2025

Report

Report Number
MW5178298
Event Type
Other
Date Received
October 29, 2025
Date of Event
February 25, 2025
Report Date
October 26, 2025
Manufacturer
BAYER HEALTHCARE, LLC
Product Code
HHS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THIS STARTED YEARS BEFORE (B)(6) 2025, HOWEVER, THAT'S THE DATE IT ALL CHANGED MY HEALTH. IN 2009/2010 MY DOCTOR IMPLANTED THE ESSURE COILS, OVER THE YEARS THE SYMPTOMS STARTED TO GET WORSE, I DIDN'T FEEL HEALTHY, BUT I KEPT GOING WITH MY LIFE, BECAUSE I HAD TOO, THROUGH EXTREME FATIGUE, PAIN, DISCOMFORT, WEIGHT GAIN,, STRUGGLING TO BREATHE, OUT OF BREATH AS THOUGH I RAN A MARATHON; UNBEARABLE CRAMPS, EXTREMELY BAD MENSTRUAL CYCLES LIKE HEAVY BLEEDING/HEMORRHAGING WITH BLOOD CLOTS DUE TO ESSURE COILS. THE MIGRATION OF THE ESSURE COILS, I'D FIGHT OFF THE NUMEROUS COMPLICATIONS OF THE ESSURE COILS, INCLUDING THE BLOOD CLOT THAT CAUSED ME TO HAVE A STROKE ON (B)(6) 2025. WITH A BLOOD PRESSURE INCREASE OF 200/135, AT THE AGE OF 50, WHILE MY BODY WAS REJECTING THE ESSURE COIL IMPLANTS ALL THE YEARS. DURING THAT TIME IT WAS A GRADUAL DECLINE IN MY HEALTH WITH WORSENING SYMPTOMS AND PAIN. THE ONLY WAY TO RID OF THE ESSURE COILS WAS BY SURGERY, A FULL HYSTERECTOMY, HOWEVER, WHEN FIRST IMPLANTED, I (A PATIENT) WAS NEVER INFORMED OF THAT A COMPLETE HYSTERECTOMY WOULD HAVE TO BE PERFORMED. ALSO, AS A PATIENT WITH ESSURE COILS IMPLANTS, I WAS NEVER NOTIFIED BY ANY PHYSICIAN, LETTER, CLASS ACTION LAWSUIT TAKING PLACE, I WAS NOT INFORMED BY ANYONE OR ADVISED BY ANYONE THAT I SHOULD BE PART OF THE LAWSUIT AGAINST THE COMPANY THAT MANUFACTURED A DEVICE THAT WOULD CAUSE LIFE LONG HARM, PAIN AND SUFFERING OR EVEN DEATH; THE BLOOD CLOT FROM THE ESSURE COIL IMPLANTS WAS LIFE THREATENING TO ME. ON (B)(6) 2025, I WENT ON MEDICAL LEAVE FROM MY EMPLOYER AND I AM CURRENTLY ON MEDICAL LEAVE AS OF TODAY (B)(6) 2025. IN (B)(6) AND IN (B)(6) 2025, I ADVOCATED FOR MYSELF, I CALLED MY OB/GYN (OBSTETRIC AND GYNECOLOGIST) TO GET AN APPOINTMENT, HOWEVER, HER OFFICE WAS COMPLETELY BOOKED AND NO OPEN SCHEDULES TO GET RIGHT IN, EVEN MENTIONING THE COMPLICATIONS I WAS HAVING AND WORSENING. I HAD TO DEMAND A SOONER APPOINTMENT, THERE WAS NO MORE TIME TO WASTE, AS MY HEALTH WAS CONTINUOUSLY DECLINING. MY OB/GYN FINALLY GOT ME IN SO I COULD EXPLAIN MY HEALTH, SYMPTOMS, DISCOMFORT, ETC. SHE ADVISED OF THE LAPAROSCOPIC HYSTERECTOMY. WE THEN SCHEDULED THE SURGERY FOR (B)(6) 2025, THE VAGINAL ULTRASOUND WAS PERFORMED FOR ANY ABNORMALITIES, WHICH SHOWED CYSTS AND POLYPS, A CYSTS THAT WAS BY THE MIGRATED ESSURE COIL, THE SURGERY HAD TO BE RESCHEDULED UNTIL THE TEST WAS COMPLETED BY PATHOLOGY SPECIALISTS. AFTER DAYS OF WAITING, THE RESULTS WERE THANKFULLY BENIGN AND THE LAPAROSCOPIC HYSTERECTOMY SURGERY WAS SCHEDULED FOR (B)(6) 2025-- TO REMOVE ALL OF MY REPRODUCTIVE ORGANS AND TO FULLY REMOVE THE ESSURE COILS. ONCE THE ESSURE COILS WERE REMOVED, MY BODY WAS FINALLY HEALING. I NOTICED A TREMENDOUS IMPROVEMENT/DIFFERENCE. I HAD ENERGY, I COULD FINALLY BREATHE WITHOUT STRUGGLING, ALL OF THE SYMPTOMS WERE NO LONGER PRESENT. IF I WOULD HAVE KNOWN THE ESSURE IMPLANTS COULD HAVE CAUSED ME SO MANY HEALTH ISSUES OR EVEN DEATH, I WOULDN'T HAVE GOT THOSE IMPLANTS, NOR PUT MYSELF IN HARMS WAY. WHEN THE ESSURE COILS WERE IMPLANTED YEARS AGO, I BELIEVED I WAS PREVENTING ANY HARM TO MY BODY, THAT IT WAS SOMETHING GOOD. HOWEVER, THOSE ESSURE COILS WERE A THREAT TO MY HEALTH, TO MY BODY, AND MY WAY OF LIFE. NOW, I AM UNFORTUNATELY LEFT WITH THE AFFECTS OF THE STROKE, THE ESSURE COILS CAUSED, THAT I WILL HAVE FOR THE REST OF MY LIFE. I AM BRINGING ALL OF THIS TO YOUR ATTENTION BECAUSE THIS IS MY TIME, THAT I NEVER GOT, TO PROVIDE YOU WITH MY COMPLICATIONS AND LIFE THREATENED BY THE ESSURE COILS IMPLANTED INTO MY BODY. NO ONE REACHED OUT TO ME, AND I WAS UNFORTUNATELY LEFT OUT OF THE LAWSUIT AGAINST THE COMPANY THAT MANUFACTURED THESE SILENT KILLERS INTO WOMEN'S BODIES. THIS HAPPENED TO ME AND I WAS LEFT OUT OF GAINING ANY SETTLEMENT(S) THAT WAS OWED TO ME FOR PUTTING MY BODY, MY HEALTH IN A TREMENDOUS HARMFUL WAY. THE MANUFACTURER DID THIS TO ME, AND KNOWING, WHAT WE DIDN'T KNOW! PATIENT CODE: 1849, 1994, 2330, 2607, 1816, 2543, 1888, 1959, 4417, 1908, 1800. DEVICE CODE: 4003, 1524. REFERENCE REPORTS: MW5178299.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1702668 ESSURE COILS TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER HEALTHCARE, LLC

Patients

Seq Age Sex Outcome Treatment
1 51 YR Female Other| L